These vials of injectable steroid were made by New England Compounding Center, implicated in a fungal meningitis outbreak. / AP / File

Written by

Walter F. Roche Jr.

The Tennessean

The U.S. Food and Drug Administration has issued a warning letter to a South Carolina drug company charging that it violated the same provisions of federal law that were violated by the company responsible for a deadly nationwide fungal meningitis outbreak.

The four-page letter charges that Medi-Fare Drug and Home Health Center was compounding drugs without patient-specific prescriptions and was acting as a drug manufacturer. The firm was cited for multiple other violations including allowing drugs to become adulterated.

“The agency is particularly concerned about the large-scale distribution of compounded sterile drugs to health care facilities nationwide when compliance with appropriate standards for large-scale sterile production may not have been met, potentially putting patients at risk,” Clark-Lynn wrote in an email response to questions.

The FDA action follows the meningitis outbreak that has taken the lives of 14 Tennessee patients due to tainted drugs shipped across the country by the New England Compounding Center.

State and federal regulators have cited NECC for failing to have patient-specific prescriptions and for multiple sanitary violations.

Clark-Lynn said the targeted effort is being coordinated with state boards that regulate pharmacies and will include collecting data to determine which drug compounders are engaging in “large-scale sterile production.”

The warning letter cites Medi-Fare for distributing unapproved new drugs that do not qualify for an exemption from federal requirements for a drug manufacturer. In addition, FDA inspectors found that air filters were inadequate and the clothing of the workers handling the drugs did not meet sterility standards.

The letter also cites inadequate labeling on Medi-Fare’s products.

Clark-Lynn said the current focus on firms producing sterile drug products was due to the increased risk to patients from those compounds.

She said the FDA trained the inspectors involved in the effort to determine “compliance with aseptic processes.”

Calling the fungal meningitis outbreak “the most recent and most serious” such event in a decade, Clark-Lynn said the agency will also continue “to conduct for-cause inspections when we receive reports or complaints about serious adverse events related to drugs made by pharmacies.”